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  • Section VI / Chapter 2 - Page 1

    Section VI (previously Section V of Oregon OSHAs Technical Manual)

    HEALTH CARE FACILITIES

    CHAPTER 1: HOSPITAL INVESTIGATIONS: HEALTH HYAZARDS

    CHAPTER 2: CONTROLLING OCCUPATIONAL EXPOSURE TO HAZARDOUS DRUGS

    CHAPTER 3: [RESERVED]

  • Section VI / Chapter 2 - Page 2

    SECTION VI: CHAPTER 2

    CONTROLLING OCCUPATIONAL EXPOSURE TO

    HAZARDOUS DRUGS

    Chapter Revision Information:

    This chapter was previously identified as Section V, Chapter 3 in Oregon OSHAs circa 1996 Technical Manual. The section number

    was modified from Section V to Section VI in March 2014 to provide

    uniformity with federal OSHAs Technical Manual (OTM).The chapter

    number was modified from Chapter 3 to Chapter 2.

    In March 2014, the chapters multilevel listing format was modified from an alphanumeric system to a roman numeral system.

    In March 2014, all references to Material Safety Data Sheets (MSDS) were changed to Safety Data Sheets (SDS).

    In March 2014, all references to OSHA 200 Log were changed to OSHA 300 Log.

    In March 2014, a reference to 29 CFR 1910.133 was replaced with OAR 437-002-0134.

    In March 2014, a reference to 29 CFR 1910.20(Employee Records) was replaced with 29 CFR 1910.1020 (Access to Employee Exposure

    and Medical Records).

  • Section VI / Chapter 2 - Page 3

    SECTION VI: CHAPTER 2

    CONTROLLING OCCUPATIONAL EXPOSURE TO

    HAZARDOUS DRUGS

    TABLE OF CONTENTS

    I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

    II. CATEGORIZATION OF DRUGS AS HAZARDOUS . . . . . . . . . . . . . 5

    A. Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

    B. Hazard Definition Based on Pharmacology/Toxicology. . . . . . . . . . . 6

    III. BACKGROUND: HAZARDOUS DRUGS AS OCCUPATIONAL

    RISKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    7

    A. Mechanism of Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

    B. Animal Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

    C. Human Data at Therapeutic Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

    D. Occupational Exposure: Airborne Levels . . . . . . . . . . . . . . . . . . . . . 8

    E. Occupational Exposure: Biological Evidence of Absorption . . . . . . . 9

    F. Occupational Exposure: Human Effects . . . . . . . . . . . . . . . . . . . . . . . 10

    IV. WORK AREAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

    A. Pharmacy or Other Preparation Areas . . . . . . . . . . . . . . . . . . . . . . . . . 11

    B. Administration of Drugs to Patients . . . . . . . . . . . . . . . . . . . . . . . . . . 12

    C. Disposal of Drugs and Contaminated Materials . . . . . . . . . . . . . . . . . 12

    D. Survey of Current Work Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

    V. PREVENTION OF EMPLOYEE EXPOSURE . . . . . . . . . . . . . . . . . . . 13

    A. Hazardous Drug Safety and Health Plan . . . . . . . . . . . . . . . . . . . . . . . 13

    B. Drug Preparation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

    C. Work Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

    VI. MEDICAL SURVEILLANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

    A. Pre-Placement Medical Examinations . . . . . . . . . . . . . . . . . . . . . . . . . 27

    B. Periodic Medical Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

    C. Postexposure Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

    D. Exit Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

    E. Exposure-Health Outcome Linkage . . . . . . . . . . . . . . . . . . . . . . . . . . 28

  • Section VI / Chapter 2 - Page 4

    TABLE OF CONTENTS (CONTINUED)

    F. Reproductive Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

    VII. HAZARD COMMUNICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

    A. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

    B. Written Hazard Communication Program . . . . . . . . . . . . . . . . . . . . . 30

    C. Safety Data Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

    VIII. TRAINING AND INFORMATION DISSEMINATION . . . . . . . . . . . . 31

    A. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

    B. Employee Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

    C. Employee Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

    IX. RECORDKEEPING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

    X. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

    LIST OF APPDENENDICES

    APPENDIX: 2-1 Some Common Drugs That Are Considered

    Hazardous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    42

    APPENDIX: 2-2 Some Aerosolized Drugs . . . . . . . . . . . . . . . . . . . . . . 44

  • Section VI / Chapter 2 - Page 5

    I. Introduction

    In response to numerous inquiries,1 OSHA published guidelines for the management of cytotoxic

    (antineoplastic) drugs in the work place in 1986.106

    At that time, surveys indicated little

    standardization in the use of engineering controls and personal protective equipment (PPE).56,73

    Although practices improved in subsequent years, problems still exist.111

    In addition, the

    occupational management of these chemicals has been further clarified. These trends, in

    conjunction with many information requests, have prompted OSHA to revise its

    recommendations for hazardous drug handling. In addition, some of these agents are covered

    under the Hazard Communication Standard (HCS) [Div 2 1910.1200].107

    In order to provide recommendations consistent with current scientific knowledge, this

    informational guidance document has been expanded to cover hazardous drugs (HD), in addition

    to the cytotoxic drugs (CD) that were covered in the 1986 guidelines. The recommendations

    apply to all settings where employees are occupationally exposed to HDs: such as hospitals,

    physicians' offices and home health care agencies. It is recognized that sections dealing with

    work areas and prevention of employee exposure refer to workplaces where pharmaceuticals are

    used in concentrations appropriate for patient therapy. In those settings where employees work

    with drugs in a more potentially hazardous form, such as a more concentrated form in some

    components of pharmaceutical manufacturing, measures that afford employees a greater degree

    of protection from exposure are commonly employed and should be used.

    This review will:

    Provide criteria for classifying drugs as hazardous,

    Summarize the evidence supporting the management of HDs as an occupational hazard,

    Discuss the equipment and worker education recommended as well as the legal requirements of standards for the protection of workers exposed and potentially exposed

    to HDs,

    Update the important aspects of medical surveillance, and

    List some common HDs currently in use.

    Anesthetic agents have not been considered in this review. However, exposure to some of these

    agents is a recognized health hazard,104

    and they have been considered in a separate

    Technical Manual Chapter.

    II. Categorization of Drugs as Hazardous

    The purpose of this section is to describe the biological effects of those pharmaceuticals which

    are considered hazardous. A number of pharmaceuticals in the health care setting may pose

    occupational risk to employees through acute and chronic workplace exposure. Past attention

    focused on drugs used to treat cancer. However, it is clear that many other agents also have

    toxicity profiles of concern. This recognition prompted the American Society of Hospital

  • Section VI / Chapter 2 - Page 6

    Pharmacists (ASHP) to define a class of agents as "hazardous drugs."3 That report specified

    concerns about antineoplastic and non-antineoplastic hazardous drugs in use in most institutions

    throughout the country. OSHA shares this concern.

    A. Characteristics

    The ASHP Technical Assistance Bulletin (TAB) described four drug characteristics, each of

    which could be considered hazardous:

    genotoxicity,

    carcinogenicity,

    teratogenicity or fertility impairment, and

    serious organ or other toxic manifestation at low doses in experimental animals or treated patients.

    Appendix VI:2-1 of this review lists some common drugs which are considered hazardous by the

    above criteria. There is no standardized reference for this information nor is there complete

    consensus on all agents listed.

    B. Hazard Definition Based on Pharmacology/Toxicology

    Professional judgment by personnel trained in pharmacol